Regulatory Affairs ContractorMust be based in Poland or Spain!Opportunity to contribute to high-impact regulatory submissions in a dynamic, collaborative setting (6 month full-time contract).Key Responsibilities:
Support EU regulatory development strategies and execution for key pipeline programs.Prepare, submit, and manage CTAs (applications via CTIS) and contribute to the preparation of initial MAAsAssist in the development and submission of Paediatric Investigational Plans (PIPs) and full waiver requests.Prepare for and participate in EMA and national Health Authority meetings ,
including Scientific Advice and regulatory briefings.Monitor and interpret evolving EU regulatory guidelines relevant to ongoing studies and development plans.Key Requirements:
7+ years of Regulatory Affairs experience in the pharmaceutical or biotech industry.Hands-on experience with EU CTAs via CTIS, including submitting initial applications and maintenance.Prior experience with MAA submissions, scientific advice and PIPsEU regulatory experience essential, US desirableExperience working in or supporting small biotech, pharma, or CRO environments and exposure to global team environments
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